Associate Principal Scientist, Preclinical Development

Biopharma Careers; Rahway, Northern (NJ, KY); Hybrid; USD 140,000 - 200,000; Full time

Job summary

Merck in Rahway, New Jersey seeks an Associate Principal Scientist to advance biologics sterile product development. The role emphasizes designing experiments, executing plans, and analyzing data to support non-oral dosage forms from preclinical to commercialization.

You will collaborate with biologics and biopharmaceutics teams, lead project activities at external sites, and contribute to regulatory filings while mentoring scientists and driving innovation in drug product development.

Qualifications

• PhD in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industry experience.
• B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Responsibilities

• Lead/contribute towards innovative approaches for biologics sterile product development with experimental design and data analysis.
• Support early and late-stage development candidates including robust drug product composition and scalable process development.
• Lead and mentor scientists, influence cross-functional teams, and communicate with key stakeholders.

Education

PhD in Chemical/Biomedical/Pharmaceutical Engineering or related

BS/MS in Engineering or Pharmaceutical Sciences

Job description

# Associate Principal Scientist, Preclinical DevelopmentRahway, New Jersey, United States of America FULL\\_TIMENotify me about similar jobsView Full Job & Apply at MerckMerck is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunity**Job Description**The Sterile Product Development (SPD) group is responsible for developing non-oral dosage forms (injections, implants, inhaled, ocular) for small, intermediate, and large molecules from preclinical toxicology studies to commercialization. Our development teams ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. During development, we leverage smart experimental design, cutting edge analytical tools, and predictive approaches to inform molecule, formulation and process selection. In summary, our team enables the translation of preclinical candidates into non-oral drug products.Our team is looking for a candidate for the position of Associate Principal Scientist (R4) supporting the Biologics & Biopharmaceutics Team within Sterile Product Development.**Primary duties:**Lead/ contribute towards the new, innovative approaches for biologics sterile product development through the generation of experimental designs, execution of experimental plans and data analysisSupport both early and late-stage development candidates, including screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Build deep fundamental knowledge around the drug product to ensure completion of key milestones and laboratory / regulatory documentation.Active strategic and technical leadership on program development teams, interfacing with key stakeholders, and collaborating across functions to drive defined milestones will be required.Responsible for leading and championing organizational strategic and innovation objectives aligned with organizational goals.Be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.Leads project activities at external manufacturing sites including tech transfersEnhance our Company's professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovationsMaintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others**Education Minimum Requirement:**Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industry experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.